Complying With Final Rule Revising the Common Rule for Clinical Trials and Human Research

Recording of a 90-minute CLE webinar with Q&A


Conducted on Tuesday, February 28, 2017
Recorded event now available


This CLE webinar will provide guidance to counsel for navigating the changes to the Common Rule for clinical trials and human subjects research. The panel will examine the practical impact for stakeholders, such as hospitals, research organizations and drug manufacturers, and will outline compliance strategies to meet the new requirements.

Description

On Jan. 19, 2017, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies published a final rule to revise the Federal Policy for the Protection of Human Subjects (the Common Rule), which governs research involving human subjects. The majority of the rule’s provisions take effect in Jan. 2018.

The Common Rule has been in place since 1991, and the revisions provide a regulatory update in light of the many changes in the healthcare and life sciences industries since that time. The final rule addresses issues concerning informed consent, secondary research use of information and biospecimens, harmonization with the HIPAA Privacy Rule, review of multi-site research, and more.

Attorneys advising stakeholders in healthcare and the life sciences, including drug and device manufacturers, hospitals, academic medical centers, universities and medical schools, and institutional review boards, must fully understand the scope and complexity of the changes to the Common Rule to ensure clients are in full compliance.

Listen as our authoritative panel examines the changes to the Common Rule for clinical trials and human research. The panel will provide guidance on the new requirements and discuss the impact on stakeholders involved in clinical trials and human research. The panel will outline compliance strategies to meet the new requirements.

Outline

  1. Common Rule changes
  2. Impact on the regulatory landscape
  3. What providers and counsel need to do to ensure compliance

Benefits

The panel will review these and other key issues:

  • How do the revisions to the Common Rule change the requirements for human subjects research, including clinical trials?
  • What will the practical impact be on organizations involved in clinical trials or human research?
  • What steps must healthcare industry stakeholders take to ensure compliance by Jan. 2018?

Faculty

Abram S. Barth, Esq.
Ropes & Gray, New York

Mr. Barth has a wide range of experience counseling on FDA regulation, with a particular focus on medical devices, combination products and clinical research. He formerly worked in the FDA’s Office of Chief Counsel, most recently as Associate Chief Counsel, serving as Team Leader of the Device Practice Group. Mr. Barth has significant experience advising clients on the life cycle of medical devices, including clinical trials, premarket submissions, advertising and promotion, quality system regulation, medical device reporting, and postmarket surveillance and studies, as well as the premarket and postmarket regulation of combination products.

Emily Marcus Levine, Senior Attorney
U.S. Department of Health and Human Services, Rockville, Md.

Ms. Levine is a Senior Attorney with the Public Health Division of the Office of the General Counsel, U.S. Department of Health and Human Services, where she has practiced public health law since 1999. Ms. Levine has provided legal advice to the Office for Human Research Protections since 2015 and was a key participant in HHS’s finalization of the final rule that amended the Common Rule. Ms. Levine also specializes in legal issues relating to organ transplantation and is an expert on vaccine injury compensation and liability.

Laura Odwazny, Senior Attorney
U.S. Department of Health and Human Services, Rockville, Md.

Ms. Odwazny’s primary client is the Office for Human Research Protections, which interprets and enforces the HHS regulations that provide protections for human research subjects. Ms. Odwazny also currently advises the Presidential Commission for the Study of Bioethical Issues and the HHS Office of Global Affairs. Throughout her 16 years with the Office of the General Counsel, Ms. Odwazny has provided legal advice to various other agencies within HHS, including the Office of the Assistant Secretary for Health, the Program Support Center Division of FOIA Services, the Health Resources and Services Administration, and the Substance Abuse and Mental Health Administration. Ms. Odwazny has served as an adjunct professor at American University Washington College of Law, teaching “The Law and Ethics of Human Subjects Research,” and currently teaches “Compliance in Research” for the University of Pittsburgh School of Law Health Care Compliance Certificate program.

David Peloquin, Esq.
Ropes & Gray, Boston

Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the area of clinical research and health data privacy. Prior to attending law school, he worked as a project manager for a leading supplier of electronic medical records. Mr. Peloquin is a frequent author and lecturer on clinical research/human subject protection issues, among others.


Recordings

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Customer Reviews

The presentation materials were clear and logical. Presenters were knowledgeable and their respective presentations dovetailed nicely.

Susan Lahti

NMDP

Very concise - provided what was needed, yet also included many examples, thoughts and ideas.

Ron Keith

Skilled Care

The seminar tackled a difficult issue that we need to understand better.

Evan Smith

Beazley

The webinar was clearly presented and organized. It was a good mixture of the law and practice.

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I liked that the slides automatically moved along with the presentation of each speaker.

Ann Marie Henderson

Staten Island University Hospital

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Health Law Advisory Board

Lowell C. Brown

Partner

Arent Fox

Jennifer L. Evans

Shareholder

Polsinelli

Ryan S. Johnson

Shareholder

Fredrikson & Byron

Gina M. Kastel

Partner

Faegre Baker Daniels

Karen S. Lovitch

Member

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo

David A. Manko

Partner

Proskauer Rose

John J. Miles

Senior Counsel

Baker Donelson

C. Elizabeth O'Keeffe

Counsel

Wyatt, Tarrant & Combs

J. Peter Rich

Partner

McDermott Will & Emery

Donald H. Romano

Of Counsel

Foley & Lardner

Judith A. Waltz

Partner

Foley & Lardner

John R. Washlick

Shareholder

Buchanan Ingersoll & Rooney

Jesse A. Witten

Partner

Drinker Biddle & Reath

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